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RECRUITING
NCT06544473
PHASE4

Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome

Sponsor: Aarhus University Hospital

View on ClinicalTrials.gov

Summary

This 5-week, phase IV randomized crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The objective is to establish the equipotency between the two estradiol regimens by evaluating various estradiol-dependent surrogate markers. The study involves 50 women with TS, aged 18-50 years, who are randomized to receive either oral or transdermal ERT for 14 days, followed by a crossover to the alternate treatment for another 14 days, with a one-week washout period in between. Blood tests are conducted at baseline, after the first 14 days of treatment, after the washout period, and after the final 14 days of treatment. The investigators anticipate that this study will provide clinicians with a better understanding of ERT in treating women with TS.

Official title: Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome - A Randomized Study

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-11-29

Completion Date

2026-12-31

Last Updated

2024-08-23

Healthy Volunteers

No

Interventions

DRUG

17-beta estradiol

Treatment with orally administered estrogen for 14 days

DRUG

17-beta estradiol

Treatment with transdermally administered estrogen for 14 days

Locations (1)

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, Aarhus N, Denmark